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A Cohort Study to Assess Sustained Immunogenicity to qHPV Vaccine Among HIV-infected Girls and Boys Age 9-14 Years

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01446718
Recruitment Status : Active, not recruiting
First Posted : October 5, 2011
Last Update Posted : September 7, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to determine sustained immunogenicity of the quadrivalent vaccine 'Gardasil', 48 months after initial vaccination, among HIV-1 infected boys and girls age 9-14 years. This age range is within the World Health Organization (WHO) stipulated guidelines for national programs for the vaccine.

Condition or disease Intervention/treatment Phase
Human Papillomavirus HIV-1 Infection Biological: Gardasil vaccine Phase 4

Detailed Description:

HIV-infected individuals bear a disproportionate disease burden of HPV-related diseases suggesting more rapid progression from HPV acquisition to malignancy. HIV infected women have a 2-22 fold increased risk for cervical cancer compared to uninfected women. The quadrivalent HPV vaccine marketed as "Gardasil" has demonstrated efficacy against type specific HPV infections known to cause 70% cervical cancer (HPV 16 & 18) and HPV 6 & 11 known to cause 90% of anogenital warts in populations of HIV negative young women.

Since the risk of HPV exposure persists throughout a person's sexual life, the duration of protection, especially when the vaccine is given in the pre-adolescent period, is critical to overall vaccine effectiveness. Extended follow up of HIV-uninfected individuals has shown sustained response to HPV vaccine for 8.4 and 6 years respectively to the bivalent and quadrivalent vaccines. However, other vaccines such as the hepatitis B vaccine have been shown to require additional dosages to be effective among HIV-infected persons.

Data on immunogenicity of the HPV vaccine among HIV infected adolescents is limited to a 12 month follow up period.

Current HPV vaccine guidelines target pre-sexual adolescents. Since the risk of HPV exposure persists throughout an individual's sexual life, the duration of protection provided by vaccination is critical to the overall vaccine effectiveness. Duration of sustained HPV 6/11/16/18 antibody response is directly related to vaccine effectiveness and determines the need for booster dosing.

The investigators therefore propose to extend follow up of 179 girls and boys in Kenya, age 9-14 years who have received 3 doses of the quadrivalent 'Gardasil' vaccine and assess for immunogenicity annually.

Study Location: Partners in Prevention, Thika site

Study Design

Study Type : Observational
Actual Enrollment : 179 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Longitudinal Observational Cohort Study to Assess Sustained Immunogenicity up to 48 Months to Quadrivalent Human Papillomavirus Vaccine Among HIV-infected Girls and Boys Age 9-14 Years in Kenya
Study Start Date : December 2014
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Gardasil Vaccine
This is an extension of follow up for participants who received 3 doses of Gardasil vaccine in the "Immunogenicity and Safety of Quadrivalent Human Papillomavirus Vaccine in HIV-Infected Pre-Adolescent Girls and Boys in Kenya" study.
Biological: Gardasil vaccine
0.5ml of intramuscular vaccine in three doses
Other Name: Gardasil

Outcome Measures

Primary Outcome Measures :
  1. immune response to vaccine specific HPV types [ Time Frame: 48 months ]
    antibody response to HPV type 6, 11, 16, 18 measured by cLIA

Secondary Outcome Measures :
  1. immune response to vaccine specific HPV types [ Time Frame: 48 months ]
    HPV infection among sexually active HIV infected adolescents

Biospecimen Retention:   None Retained
Plasma for HPV antibody testing there will be no long term sample storage

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Study participants will be enrolled from the paediatric HIV-care clinic

Inclusion Criteria:

  • HIV-infected
  • age 9-14 years
  • guardian/parental consent

Exclusion Criteria:

Participants will be excluded if they

  • are severely ill as defined by Karnofsky <70
  • have a diagnosis of malignancy
  • on-going febrile illness (temperature ≥37.8°C), including active treatment for an opportunistic infection
  • have received systemic corticosteroids within prior one year
  • have received inactivated vaccine within prior 2 weeks, or live attenuated vaccine within prior 6 weeks
  • have history of allergy to any products included in the HPV vaccine
  • have received any of blood derivatives within prior 6 months
  • are pregnant
  • lack parental consent and/or parent declines to provide assent
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01446718

Sponsors and Collaborators
Kenyatta National Hospital
University of Washington
Merck Sharp & Dohme Corp.
Kenya Medical Research Institute
Principal Investigator: Nelly R Mugo, MMed, MPH Kenya Medical Research Institute (KEMRI)
More Information

Responsible Party: Nelly R. Mugo, Dr., Kenya Medical Research Institute
ClinicalTrials.gov Identifier: NCT01446718     History of Changes
Obsolete Identifiers: NCT01998178
Other Study ID Numbers: (MISP)IISP 51802
First Posted: October 5, 2011    Key Record Dates
Last Update Posted: September 7, 2016
Last Verified: September 2016

Keywords provided by Nelly R. Mugo, Kenya Medical Research Institute:
quadrivalent vaccine
Human Papillomavirus

Additional relevant MeSH terms:
Immunologic Factors
Physiological Effects of Drugs